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News
The FDA has granted fast track designation to Yutrepia (treprostinil inhalation powder) for Raynaud's phenomenon linked to systemic sclerosis — a condition affecting ~95% of SSc patients with few good treatment options. The phase 2a RE-WARM trial, enrolling ~75 adults across 30 U.S. sites, is set to kick off in October. The designation will speed up FDA communication and regulatory review.
The FDA has granted fast track designation to Yutrepia — an inhalable dry-powder formulation of treprostinil made by Liquidia — for the treatment of Raynaud's phenomenon associated with systemic sclerosis (SSc). Already approved for pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease, Yutrepia is now being evaluated for a new, serious indication with a significant unmet need.
Raynaud's phenomenon affects roughly 95% of SSc patients and can cause far more than cold-weather discomfort. Recurrent reductions in blood flow can lead to severe pain, loss of hand function, digital ulcers, infection, and in the worst cases, gangrene and amputation. Despite this, current treatment options are limited, often used off-label, and may carry systemic side effects.
The phase 2a RE-WARM trial — led by Dr. Dinesh Khanna of the University of Michigan — will assess the safety and pharmacodynamics of Yutrepia in approximately 75 U.S. adults across 30 sites, with enrollment expected to begin in October 2026.
Key Takeaways:
Why it matters: For rheumatologists managing SSc, this designation is a meaningful step toward filling a long-standing treatment gap — one that affects the vast majority of their SSc patients and significantly impacts quality of life.
